M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVES: I. To determine the recommended phase II dose (RP2D) of eribulin mesylate (eribulin) when in combination with the fixed dose of bintrafusp alfa (M7824) in patients with metastatic triple-negative breast cancer (TNBC). II. To evaluate the safety and tolerability of M7824 when in c...

PRIMARY OBJECTIVES: I. To determine the recommended phase II dose (RP2D) of eribulin mesylate (eribulin) when in combination with the fixed dose of bintrafusp alfa (M7824) in patients with metastatic triple-negative breast cancer (TNBC). II. To evaluate the safety and tolerability of M7824 when in combination with eribulin in patients with metastatic TNBC. SECONDARY OBJECTIVES: I. To determine the best overall response (BOR) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. II. To determine the overall response rate (ORR). OTHER OBJECTIVES: I. To assess immunologic/molecular responses to M7824 in combination with eribulin in patients with metastatic TNBC. II. Estimation of progression-free survival (PFS) in metastatic TNBC patients treated with M7824 in combination with eribulin. III. Perform correlative studies on blood and tissue samples to evaluate systemic and tumor biomarkers of response and resistance to M7824 and eribulin. IV. Correlative studies on blood and tissue samples will also be used to evaluate systemic and tumor biomarkers of response to M7824 and eribulin. OUTLINE: Patients receive bintrafusp alfa intravenously (IV) over 50-80 minutes on days 1, 15, and 29, and eribulin mesylate IV over 2-5 minutes on days 1, 8, 22, and 29. Treatment repeats every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 90 days.

Tracking Information